ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30— 510(k) K081545

Name: FDA 510(k) clearance K081545
Creator: U.S. Food and Drug Administration
Published: 2008-10-02

Substantially Equivalent

Advanced Medical Optics, Inc.

FDA 510(k) clearance K081545 for ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30, Substantially Equivalent on 2008-10-02. Applicant: Advanced Medical Optics, Inc.. Device class: 1.

Clearance details

Applicant: Advanced Medical Optics, Inc.
Product code: Code MSS
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 2008-06-02
Decision date: 2008-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSS

product code MSS

Injury: 385
Malfunction: 2,033
Total: 2,418

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.